Kornimate/medical-research-clean huggingface dataset:
study to learn the effect of drug bay1817080 on the way the body absorbs, distributes and excretes another drug rosuvastatin in healthy adult participants

Conditions: Drug Interactions

Summary: researchers in this study want to learn how the study drug bay1817080 interacts with another drug called rosuvastatin (brand name: crestor) and affects the way the body absorbs, distributes and excretes rosuvastatin in healthy adult male and female participants (drug-drug interaction study). the study drug bay1817080 is a new drug under development with a goal to suppress pain and chronic cough. it works by binding to and blocking proteins related to pain in the body. rosuvastatin is an approved and marketed drug to lower high levels of "bad" cholesterol (a waxy, fat-like substance found in blood). both drugs interact with the same proteins (molecules) in the human body, and as a result, the study drug may affect the way rosuvastatin is taken up and used by the body when applied together. participants in this study will be asked to visit the clinic 3 times over a period of 3 to 4 weeks. each participant will receive rosuvastatin tablets twice with at least 11 days in between and the study drug tablets twice daily for 14 days. blood samples will be taken from the participants to measure the blood levels of rosuvastatin.

the primary objective of the study is to investigate the influence of multiple doses of bay1817080 on the pharmacokinetics of rosuvastatin given concomitantly. secondary objective is to investigate the safety of bay1817080.

Eligibility criteria:
inclusion criteria: * participant is healthy as determined by the investigator * white or black race * body mass index (bmi) ≥ 18.0 and ≤ 30.0 kg/m² at screening * body weight of at least 50 kg at screening exclusion criteria: * known or suspected allergy or hypersensitivity to bay1817080, rosuvastatin or any of their excipients * asian race * contraindications to rosuvastatin * any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first study intervention administration or during the study until follow-up (occasional use of ibuprofen is permissible) * history of or positive covid-19 test or contact with covid-19 positive subject in past 4 weeks

Keywords: p2x3 receptor antagonist rosuvastatin organic anion transporting polypeptide 1b1 (oatp1b1) organic anion transporting polypeptide 1b3 (oatp1b3) breast cancer resistance protein (bcrp) pain chronic cough cholesterol
a study of the safety and efficacy of synvisc in patients with symptomatic shoulder osteoarthritis

Conditions: Osteoarthritis; Musculoskeletal Diseases

Summary: this clinical study is to evaluate the safety and efficacy of synvisc in patients with symptomatic shoulder osteoarthritis (oa). patients will be given synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.


Eligibility criteria:
inclusion criteria: * patients with symptomatic oa pain of shoulder (gleno-humeral) exclusion criteria: * patients with current or prior conditions or treatment that would impede measurement of efficacy or safety

Keywords: osteoarthritis of the shoulder musculoskeletal
combined ketorolac and lidocaine paracervical block for office hysteroscopy

Conditions: Abnormal Uterine Bleeding; Analgesia; Paracervical Block

Summary: a randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.

a randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies. primary objective: to study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. secondary objectives: to study the effect of a combined ketorolac and lidocaine paracervical block on patient satisfaction and post procedure pain. to assess for major adverse events with the use of a combined ketorolac and lidocaine paracervical block for office hysteroscopy when compared with a standard lidocaine paracervical block. primary endpoint: pain on a 100 mm visual analogue scale during cervical dilation. secondary endpoints: pain on a 100 mm visual analogue scale during the paracervical block, during the office hysteroscopy, immediately after the hysteroscopy, and 30 minutes after the procedure. other secondary endpoints include patient satisfaction, frequency of procedure termination, and adverse events. patients assigned female at birth, booked for office hysteroscopy at mount sinai hospital faculty practice associates. patients scheduled for office hysteroscopy through seeing a gynecologist at either 5 e 98th street faculty practice associates or 1176 5th avenue gynecology practice. 5 e 98th street primarily cares for privately insured patients, while 1176 5th avenue cares for a mix of privately insured as well as patients insured with medicaid. regardless of recruitment site, all office hysteroscopies will be performed at the 5 e 98th street facility. a randomized controlled trial designed to investigate if ketorolac added to a paracervical block reduces procedure related pain. patient will be randomized to a standard paracervical block versus a paracervical block with ketorolac added. the study will be conducted over two years. patients will be followed for the duration of the two-year study period.

Eligibility criteria:
inclusion criteria: * patients assigned female at birth, * booked for office hysteroscopy at mount sinai hospital faculty practice associates. exclusion criteria: * allergy to ketorolac or non-steroidal anti-inflammatory medications * allergy to lidocaine * presence of thrombocytopenia * contraindications to lidocaine * history of gastritis or gastric ulcer * acute renal failure or chronic renal disease * chronic liver disease * history of bleeding diathesis * long term narcotic use
an open-label study of two formulations of lx1033 in healthy human subjects

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of lx1033 in normal healthy volunteers.


Eligibility criteria:
inclusion criteria: * adult subjects age 18 to 55 years * vital signs acceptable at screening * body mass index (bmi) between 18 and 35 kg/m\^2 at screening * considered to be in good health, as determined by the investigator * normal ecg findings * negative urine screen for drugs of abuse and negative breath test for alcohol * negative hepatitis b surface antigen, hepatitis c antibody, and hiv1 and hiv2 antibody tests within the last 28 days * ability to provide written informed consent exclusion criteria: * use of any medication (including acetaminophen) within 5 days of dosing * use of any investigational agent or selective serotonin reuptake inhibitors (ssris) within 30 days of study start * administration of any protein or antibodies within 90 days of study start * donation or loss of greater than 450 ml of blood within 45 days of study start * known history of hepatic disease or significantly abnormal liver function tests * history of alcoholism or substance abuse within 3 years prior to study start * participation in any other clinical study within 30 days preceding the first dose of study drug * positive serum pregnancy test
feasibility study of retinal screening using the retinavue 100 camera in outpatient dialysis centers

Conditions: Kidney Failure, Chronic; Eye Diseases; Diabetic Retinopathy

Summary: the purpose of this research study is to look at retinal abnormalities in outpatient renal dialysis patients using the fda approved retinavue 100 hand-held (non-mydriatic) camera.

there are no studies evaluating (diabetic or non-diabetic) retinopathy in the renal dialysis patient population (\~300,000 americans). approximately 50% of this population has end-stage retinal disease (esrd) due to diabetes. dialysis patients are among the most debilitated patients, and thus, have even more barriers to receiving their recommended annual retinal evaluation. the advent of the retinavue hand-held retinal camera holds great promise in this population, as dialysis patients access medical care 3 times a week, for several hours at a time at their dialysis clinic.

Eligibility criteria:
inclusion criteria: * the subject must currently be seeking treatment for end-stage renal disease (esrd) at one of the specified dialysis clinics. * the subject must be ≥ 18 years of age. exclusion criteria: * the subject is \<18 years of age. * no exclusions will be made on the basis of gender, ethnicity, or race.

Keywords: retinal screening outpatient dialysis
randomized-controlled trial of yoga for ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to self-care on quality of life, stress, psychological health, and physiological parameters in 77 patients with ulcerative colitis.


Eligibility criteria:
inclusion criteria: * ulcerative colitis (clinical, endoscopic and histological diagnosis) * disease duration at least 12 months * clinical remission for at least 4 weeks and less than 12 months * cai \< 5 * ibdq \< 170 * physical and mental ability to perform yoga * no regular practice of yoga or pilates in the previous 12 months exclusion criteria: * clinically active disease (cai \> 4 rachmilewitz) * complete resection of the colon * acute, infectious or chronic active ulcerative colitis * severe disease precluding yoga practice * malignancy with a disease-free survival \< 5 years except curatively treated basalioma of the skin * alcohol or drug abuse * dementia * pregnancy

Keywords: colitis, ulcerative yoga
transdiaphragmatic pressure and neural respiratory drive measured during inspiratory muscle training in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: inspiratory muscle training（imt）was an rehabilitation therapy for stable patients with chronic obstructive pulmonary disease(copd). however, its therapeutic effect remains undefined due to unclear of diaphragmatic mobilization during imt. diaphragmatic mobilization represented by transdiaphragmatic pressure（pdi）and neural respiratory drive expressed as corrective root-mean-square(rms) of diaphragmatic electromyogram(emgdi) provide vital information to select the proper imt device and loads in copd, therefore make curative effect of imt clarity. pdi and rms of diaphragmatic electromyogram (rmsdi%) was respectively measured and compared during inspiratory resistive training and threshold load training in stable patients of copd.

subjects：the diagnosis and severity of all participants were measured using the pulmonary function test according to global initiative for chronic obstructive lung disease. inclusion criteria: (1)severe and very severe copd (postbronchodilator fev1/fvc under 70% and fev1 under 50% of the predicted value (gold c and d group); (2)inspiratory muscle weakness（maximal inspiratory pressure under 60cmh2o）; (3) bronchial dilation test (bdt) negative. exclusion criteria: (1) acute exacerbation in the previous 4 weeks; (2) using the oral corticosteroids within4 weeks; (3) history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases that could interfere the study. study design this was a single-centre, cross-sectional study. intervention： inspiratory resistive training all participants conducted inspiratory resistive training using inspiratory resistive trainer (pflex, respironics inc, usa). pdi and emgdi were recorded synchronously.inspiratory resistive load was change from low intensity into moderate and high intensity randomly（inspiratory hole diameters was set to 5.3mm, 2.4mm and 1.8mm,respectively） inspiratory threshold load training inspiratory threshold load training was conducted by all participants using the inspiratory threshold load trainer (threshold inspiration muscle trainer, respironics inc, usa) .inspiratory threshold pressure was set to low, medium and high intensity randomly（threshold pressure was 30%,60% and 80% of mip, respectively). measurements ：transdiaphragmatic pressure and neural respiratory drive

Eligibility criteria:
inclusion criteria: 1. severe and very severe copd (postbronchodilator fev1/fvc under 70% and fev1 under 50% of the predicted value (gold c and d group); 2. inspiratory muscle weakness（maximal inspiratory pressure under 60cmh2o）; 3. bronchial dilation test (bdt) negative exclusion criteria: 1. acute exacerbation in the previous 4 weeks; 2. using the oral corticosteroids within 4 weeks; 3. history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases that could interfere the study.
effectiveness of video-based yoga practices for sedentary women in pandemic days

Conditions: Women

Summary: this is an observational study aiming to examine the effects of video-based yoga compared to face-to-face yoga and physical exercise practices on the physical features, respiratory capacity and sleep quality of sedentary women in pandemic days. the pranayama (respiration), asana (poses), and meditation were given to the face-to-face yoga group, and the same exercises of the face-to-face yoga group were recorded in the video for the video-based yoga group. the exercises for respiration, muscle strengthening, stabilization, and flexibility were given face-to-face to the physical exercise group.

this is an observational study aiming to examine the effects of video-based yoga compared to face-to-face yoga and physical exercise practices on the physical features, respiratory capacity and sleep quality of sedentary women in pandemic days. the respiration, poses, and meditation were given to the face-to-face yoga group, and the same exercises of the face-to-face yoga group were recorded in the video for the video-based yoga group. the exercises for respiration, muscle strengthening, stabilization, and flexibility were given face-to-face to the physical exercise group. the sessions for each group were given for a total of 6 weeks (2days/week) as 12 sessions, and 60 min. their respiration (spirometer pony-fx), sleep (pittsburgh sleep quality index), posture (new york posture rating chart), balance (single leg stance assessment, functional reach distance), functional strength (5x sit-to-stand test), fatigue (fatigue severity scale) and quality of life (whoqol-bref) were evaluated at the beginning and end of the 6 weeks. the data were assessed statistically.

Eligibility criteria:
inclusion criteria: * being between the age of 18 - 60 years, * not having any history of a systemic disease, such as musculoskeletal or neurological problems, cardiac or lung diseases, diabetes and no history of recent surgery * not having participated in a regular exercise program in the last 6 months and * not having a history of active sports engagement exclusion criteria: * not being voluntary to join the study and * missing more than three sessions during the study period

Keywords: video-based yoga posture vital capacity exercise fatigue
conversion surgery after target therapy or immunotherapy in stage iv gastric cancer

Conditions: Gastric Cancer Stage IV

Summary: in this retrospective study, investigators conducted a comprehensive investigation of the factors influencing postoperative prognosis in patients with stage iv gastric cancer undergoing conversion surgery. specifically, investigators examined the impact of targeted therapy or immune check point inhibitors (icis) in combination with preoperative chemotherapy on (1) prognostic differences based on initial progression (invading adjacent organs) and metastatic site (peritoneum, distant lymph node \[ln\]) at the time of stage iv gastric cancer diagnosis and (2) conversion surgery outcomes and pathological complete response (pcr).


Eligibility criteria:
inclusion criteria: * stage iv gastric cancer patients who underwent conversion surgery exclusion criteria: * patients who did not undergo gastrectomy * patients who underwent emergent surgery due to cancer perforation * patients with missing medical records or information
effect of respiratory virus infection on emergency admission study (every study)

Conditions: Respiratory Syncytial Virus (RSV); Respiratory Viral Infection; Acute Disease

Summary: study design is multicenter prospective registry study. participants are consecutive (non-selected, a sequential registration) patients admitted from emergency rooms of participating hospitals who meet the eligibility criteria. the primary objectives are to estimate the prevalence of and risk factors for rs and other respiratory virus infection and their effect on hospital course in patients with any respiratory symptom who admit from emergency room using a multicenter prospective registry study. the primary target virus is rs virus and the secondary target viruses are respiratory virus and other microorganisms measured by filmarray 2.1.

the investigators register consecutive patients who meet the eligibility criteria at 3 participating hospitals from electronic medical records. as a routine clinical practice, presence of respiratory symptoms using standard electronic medical record (emr) format are universally assessed at the emergency room when the patients are determined to be admitted. patients are registered if they meet the eligibility criteria and information of medical history, baseline characteristics, living status, physical findings, laboratory tests, chest x-ray, electrocardiogram, on admission are retrieved from the emrs. the nasopharyngeal swab is obtained within 24 hours after admission as a standard practice, which will be sampled at either emergency rooms or hospital wards. the swab is transferred to the onsite laboratory office to measure the filmarray 2.1 by trained technicians or physicians in charge. serum antibodies for rs virus are obtained from patients with suspected lower respiratory infection (bronchitis and pneumonia) who provided their written informed consent, at the timing of admission and 4 weeks after the admission.

Eligibility criteria:
inclusion criteria: * aged 50 years or older * admission from emergency room * having at least one of following respiratory symptoms/signs for at least 24 hours and the onset date of first symptom/sign less than 7 days before admission, which meet the acute respiratory infection (ari) case definition described below: nasal congestion, rhinorrhea, sore throat, cough, sputum, dyspnea, wheeze, crackles or rhonchi, tachypnea (\>=20 per minute), decreased saturation of oxygen (\< 95%), admission with oxygen supplementation exclusion criteria: * scheduled admission * admission for trauma care * with nasopharyngeal cavity diseases or deformity which block the nasopharyngeal sampling * admission for end of life * decline to participate the study by either informed consent or opt-out method
korean regulatory post marketing surveillance for somavert

Conditions: Acromegaly

Summary: non-interventional observational study, to identify safety and effectiveness of somavert during the post-marketing period based on the korean rmp as required by the regulations of ministry of food and drug safety (mfds)


Eligibility criteria:
inclusion criteria: all patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in korea who are eligible. exclusion criteria: patients who are contraindicated for somavert

Keywords: acromegaly, somavert, post-marketing surveillance
calcinosis cutis: therapeutic effects of extracorporeal shock wave therapy (eswt)

Conditions: Calcinosis Cutis in Connective Tissue Disease

Summary: patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. the shock wave therapy will be done in 3 sessions with one week interval. the outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers. * trial with medical device

patients with calcinosis cutis due to connective tissue disease get a shock wave therapy (medical device). the shock wave therapy will be done in 3 sessions with one week interval. the outcome parameters are: change in pain (questionnaire), size of the calcinosis (ultrasound and ct), new ulcers and intake of painkillers.

Eligibility criteria:
inclusion criteria: * age of 18 * calcinosis cutis due to connective tissue disease * information about eswt given * patient understands the study and signs the informed consent exclusion criteria: * no eswt done * cuagulopathy * sepsis * pregnancy * pace maker * severe disease in the opinion of the investigator * cardiac risk with nyha iii-iv * ehlers-danlos-syndrome
microbiological epidemiology in patients experiencing microbiological or clinical failure following reimplantation after a 2-stage exchange strategy for hip or knee prosthetic joint infection

Conditions: Bone and Joint Infection; Bacterial Infections; EPIDEMIOLOGY

Summary: this study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done. a 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation. the aim is to determine the microbiological epidemiology in patients experiencing failure following reimplantation to establish, based on the drug susceptibilities, which cement could be the most active.


Eligibility criteria:
inclusion criteria: * patients with prosthetic joint infection having had a 2-step exchange at least from the reimplantation, between 2013 and 2015. exclusion criteria: -
study to assess efficacy and safety of hp3070 in subjects diagnosed with schizophrenia.

Conditions: Schizophrenia

Summary: this study is designed to evaluate efficacy and safety of hp-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia.

this is a phase 3, randomized, double-blind, placebo-controlled, in-patient, efficacy, and safety study to evaluate hp-3070 for the treatment of schizophrenia. this study is designed to evaluate efficacy and safety of hp-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia, who are in an acute exacerbation and to assess the impacts of covariates on asenapine exposure as delivered in a patch formulation, using a population-based approach.

Eligibility criteria:
inclusion criteria: * current diagnosis of schizophrenia. * subject has panss total score ≥80, and score of 4 or more in at least 2 of the following panss items at screening and at baseline: conceptual disorganization delusions; hallucinatory behavior; unusual thought content. * subjects must be able to wear a transdermal patch for 24 hours. exclusion criteria: * subject has been diagnosed with schizophrenia less than 6 months prior to screening visit. * subject has received within 90 days of screening visit: electroconvulsive therapy; transcranial magnetic stimulation; vagal nerve stimulation; or other brain stimulation treatments * subject has experienced acute depressive symptoms within 30 days prior to screening visit that requires treatment with an antidepressant, as determined by the investigator. * currently taking clozapine for the treatment of schizophrenia. * has hypothyroidism or hyperthyroidism. * subject is currently being treated with insulin for diabetes. * subject has epilepsy or history of seizures. * positive urine pregnancy test.